510(k) K110140
K110140 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "NEUROVISION NERVE LOCATOR MONITOR". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2011
- Date Received
- January 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type